BIOLOX DELTA 1365-36-320Recalls & reported problems

Summary

The FDA's MAUDE database contains 643 adverse event reports that list this exact device (DI 10603295033622), received between Mar 6, 2014 and Sep 30, 2026 — classified as 624 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (202 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 643 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revised due to possible infection liner and head removed.DOI: (b)(6) 20260DOR: (b)(6) 2026. Affected Side: Unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50945478 ↗
• InjurySep 30, 2026Improper or Incorrect Procedure or Method

  It was reported on (b)(6) 2026, a RTC with ceramic head was performed.During the evaluation carried out post-operatively it was evident that the patient presented with a fall. This was apparently associated with a sciatic nerve injury, as well as a difference in the length of the lower extremities. The operated limb longer than the contralateral. Dr states that during the procedure he used a head 36 +1.5 mm, corresponding to the shortest option available. However, the resident of orthopedics informed him that, when reviewing the surgical expenses, the reference registered and billed corresponds to a 36 +5 mm head.According to the information provided by Dr, an error could have occurred in the delivery of the implant during the procedure. The doctor says that he requested the surgical support, identified as Óscar, the shortest head available. He also comments that the reduction was technically difficult during the surgery, although at that time he did not consider it to be related to the size of the implanted head. Revision surgery has been planned with the aim of making the change to the head of shorter length.

  Patient problems: Nerve Damage; Physical Asymmetry

  MAUDE report 50945420 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50920975 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Head and liner were removed and replaced with washout for infection.Affected Side: Unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50917814 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient had TH 8-3-26. Patient fell and sustained a femur fracture. DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected side: Unknown.

  Patient problems: Fall

  MAUDE report 50873602 ↗
• InjurySep 23, 2026Device Dislodged or Dislocated

  It was reported that on (b)(6) 2026, the patient underwent revision surgery with the product in question. A patient who had previously underwent implantation of a Corail Revision stem following TFNA removal presented with a distal femoral fracture. As there was also some degree of dislocation, stem replacement was considered. Consequently, revision surgery was performed on the same day and the Corail Revision stem was removed, and the longest Arcos stem and neck component were implanted. The surgery was completed successfully without any delay. No further information is available.This report is related to complaint (b)(4) which captures the revision surgery of the TFNA.

  Patient problems: Joint Dislocation

  MAUDE report 50871425 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that revised head liner to dual mobility for instability. No other information available.DOI: Unknown.DOR:(b)(6) 2026.Affected Side: Right.

  Patient problems: Joint Laxity

  MAUDE report 50858781 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was revised due to suspected infection.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected side: Right Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50854124 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that actis retaining stem inserter/extractor shaft broke in actis stem while trying to explant it. Removed stem due to infection, all pieces were retrieved no delay in case.Affected side: Right.

  Patient problems: Unspecified Infection

  MAUDE report 50816910 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50791219 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was having infection.DOI: Unknown. DOR: (b)(6) 2026.Affected side: Unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50732665 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported a THA revision was performed for a disassociated liner after the patient had fell down while playing pickle ball. The patient was about 3 year post-op on the day of the revision. After exposure and dislocation of the hip, and removal of the femoral head, the surgeon inspected the liner. The liner (Altrx 36/52 +4 / 10 degrees) was not really disassociated but rather had broken into a few pieces. The elevated portion of the liner (the 10 degree lip) had broken off, as well as some of the ARDs.The stem in situ is a Corail KLA size 13. The femoral head had been rubbing directly against the cup for some time, so there was some intra-articular debris. The surgeon opted to remove the cup and upsize to a size 54. He used an Emphasys multi-hole and elevated rim liner. He then used a TS Delta ceramic head size 40+5. The Corail stem was well fixed and remained in situ. The post x-rays were satisfactory and the patient is in good condition.

  Patient problems: Fall

  MAUDE report 50714499 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported I & D of an infected hip. Surgeon chose to replace the head and liner.DOI: Unknown.DOR: (b)(6) 2026.Affected side: Unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50713554 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient had an infection so doctor decided to do a wash out and replace the head and liner.DOI- (b)(6) 2023.DOR- (b)(6) 2026.Affected side- Left Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50712636 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50575656 ↗
• InjurySep 1, 2026Device Dislodged or Dislocated

  It was reported that patient was dislocating. The liner and the head were removed and a dual mobility head and liner were implanted. DOI: (b)(6) 2026,DOR: (b)(6) 2026,Affected side: Unknown.

  Patient problems: Joint Dislocation

  MAUDE report 50544721 ↗
• InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50243115 ↗
• InjuryAug 6, 2026Device Dislodged or Dislocated

  It was reported that Patient was dislocating after initial surgery. Revision surgery required.DOI: On (b)(6) 2025.DOR: On (b)(6) 2026.Affected Side: Right Hip.

  Patient problems: Joint Dislocation

  MAUDE report 50154666 ↗
• InjuryJun 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR INSTABILITY. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 25547748 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2022. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25445801 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD SUFFERED FROM PAIN DUE TO IMPLANT. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Pain

  MAUDE report 25391193 ↗
• InjuryJun 3, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 25376030 ↗
• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT BECAME INFECTED, I & D WASHOUT WAS PERFORMED WITH A HEAD AND LINER EXCHANGE. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25205988 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25175267 ↗
• InjuryMay 13, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT HAD A TOTAL HIP PERFORMED. POST-OPERATIVELY DURING RECOVERY THE PATIENT DISLOCATED THEIR HIP WHEN MOVED TO ANOTHER BED. AFTER AN X-RAY WAS TAKEN, IT WAS FOUND TO HAVE A FX AND SUBSEQUENT STEM SUBSIDENCE. DR. BROUGHT THE PATIENT BACK TO SURGERY AND REVISED HIM TO A LARGER STEM. HE ALSO HAD TO USE A LONGER HEAD. THE PATIENT WAS CLOSED IN THE USUAL FASHION. THE LOOSENING WAS FOUND TO BE NON-CEMENTED. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 25160084 ↗